FDA Medical Device Recalls (openFDA)
C.R. Bard Inc: Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
- Recall number
- Z-2536-2021
- Recalling firm
- C.R. Bard Inc
- Product
- Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
- Status
- Open, Classified
- Initiated
- 2021-08-05
- Posted
- 2021-09-23
- Terminated
- not on file
- Reason
- There is potential for packaging defects that may impact the sterile barrier.
- Root cause
- Packaging change control
- Action
- Customer letters were sent "URGENT MEDICAL DEVICE RECALL" via FedEx and email to affected consignees on August 13, 2021. Customers are asked to please Take the Following Actions: 1. Note that there may be a supply disruption in Foley catheter trays from all sources due to the current product shortage driven by this issue and other issues with third party Foley manufacturers. 2. Please check all inventory locations within your institution for the specific catalog and lot number combinations listed in Attachment 1 of this recall notice. 3. Share this recall notice with any users of the product, within your facilities, to ensure they are also aware of this recall notice. 4. If you purchased this product from a distributor, contact your distributor for further instructions. 5. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process any applicable order credit. 6. Report any adverse health consequences experienced with the use of this product to BD at the contact information below. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program BD will process order credits, including shipping costs, for all customers discontinuing use of and returning product as a result of this notification, following receipt of the completed Customer Response Form. BD has implemented actions to prevent recurrence of this product issue. The firm, BD, sent an updated letter dated October 8, 2021 informing customers of additional affected lot numbers that were distributed between March 2021 through July 23, 2021.
- Quantity
- 29,890 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10); NGFR3279, UDI (01)00801741074073(17)251228(10); NGFS1308, UDI (01)00801741074073(17)251228(10); NGFS1309, UDI (01)00801741074073(17)251228(10); and NGFS1366, UDI (01)00801741074073(17)251228(10)
- 510(k) numbers
- ["K910846"]
- PMA numbers
- not on file
- Product code
- EZC
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28